Venoclysis equipment and method of administering two different parenteral liquids therefrom



1966 BURGESS ETAL 30,

VENOCLYSIS EQU AND METHOD OF ADMINISTERING' TWO DIFFERENT, PARENTERAL LIQUIDS THEREFROM Filed Oct. 8, 1963 FIG. 4. I

FIG. 5. 24 INVENTORS 25 36 26 m/m/m 5mm //[//VZ 14. 1 011. PECHMAA/A United States Patent C 3,230,954 VENOCLYSIS EQUHMENT AND METHOD OF AD- MINISTERING TWO DIFFERENT PARENTERAL LIQUIDS THEREFROM Richard E. Burgess, Pasadena, and Hein'z A. von Peehniann, Lake View Terrace, Califi, assignors to McGaw Laboratories, Inc., Glendale, Calif., a corporation of Delaware 7 Filed Oct. 8, 1963, Ser. No. 314,724 2 Claims. (Cl. 128214) The present invention relates to venoclysis equipment in which a plurality of rubber-stoppered solution containers are connected in series for the administration of liquids to a patient through a single venipuncture, and to a method of assembling said venoclysis equipment.

When liquids, such as blood, normal saline, or other parenteral solutions are administered to a patient, it is obviously desirable to administer them through a single venipuncture. This can be accomplished by connecting two or more containers of liquid in series.

Even when only a single solution is administered to a patient, it is advantageous to connect two bottles of that solution in a series hook-up so that one bottle can be exhausted without allowing air to enter the administration set. At the nurses convenience, the first exhausted bottle, called the secondary bottle, can then be disconne'cted and a new secondary bottle substituted.

When only a single bottle of intravenous solution is used, considerable attention and nursing time must be directed to stopping the How of the solution at exactly the right time and connecting a new bottle to the administration set. If this is not done, the liquid level drops in the administration set and a major portion of the set is filled with air. In such a case, his necessary to disconnect the administration set and make a new venipuncture, or to bleed the air out of the administration set. Bleeding of the air is usually accomplished by piercing a rubber gland near the lower end of'the administration set, and withdrawing fluid, blood, and air from the administration set. Both of these alternatives are highly undesirable. The series hook-up has been available for many years with parenteral solution containers which are closed by means of screw caps. However, screw cap containers have serious disadvantages in that the screw cap must be removed from the container and replaced with an adapter cap to which the administration set is connected. This opens the container and its contents, and exposes the sterile, injectable solution to possible contamination. Despite this serious disadvantage, this type of parenteral solution container has been widely used, at least partially because of the convenience of the series hook-up.

Another type of parenteral solution container frequently preferred to those closed by screw caps comprises a glass bottle with a neck which is closed by a rubber stopper. The rubber stopper customarily has two passageways extending completely therethrough, the passagewaysbeing sealed by a separate rubber disk held onto the top surface of the stopper by an aluminum closure ring. A series hook-up can be obtained with rubber-stoppered containers, however; in this type of hook-up the solution from the secondary bottle enters the primary bottle through the air tube. This causes a great deal of agitation and mixing of the solutions, and if one of the solutions is blood, considerable cell damage and hemolysis may result.

More recently, it has been proposed to use a short dislodgeable air tube in the primary container. This tube is then pushed into an ineffective position in the primary solution container by means of a connector on the set connecting the outlet of the secondary container to the air inlet of the primary container. While this device does accomplish the highly desirable series hook-up, it

still has serious disadvantages in that the air tube must be shorter than would otherwise be the case, and may also be broken when pushed out of the stopper air passage. Also, considerable strength is usually required to dislodge the air tube, and once it is dislodged, administration from the primary container cannot be resumed until the secondary container is completely drained, and then only by allowing air to bubble through the solution in the primary container.

It is therefore an object of this invention to provide improver venocylsis equipment in which a plurality of rubber-stoppered parenteral solution containers are connected in series.

Another object of this invention is to provide venoclysis equipment in a series hook-up from which the secondary container can be disconnected and the infusion of parenteral solution from the-primary container resumed.

A still further object of this invention is to provide a venocylsis apparatus for series hook-up, in which the apparatus is easy and convenient to assemble and to disassemble.

Another object of this invention is to provide a method for connecting two rubber-stoppered parenteral solution containers in series.

Other objects and advantages of our invention will be apparent from the description, and from the drawings, in which:

FIGURE 1 is a perspective view of our venoclysis equipment showing a primary bottle and a secondary bottle connected in series;

FIGURE 2 is an enlarged perspective view of the airway .plug 16;

FIGURE 3 is a top plan 'view of the stopper closing the mouth of the primary container;

FIGURE 4 is a sectional view of the stopper taken along line 4-4 of FIGURE 3; and

FIGURE 5 is a sectional view of the stopper taken along line 55 of FIGURE 3.

In FIGURE 1, stand 3 supports by bail 4 a primary bottle 1 in a mouth-downward position. Bottle 1 contains a parenteral solution such as 5% dextrose. Closing the mouth of this primary bottle 1 is a stopper 8 secured to the mouth by a closure band 9. The bottle 1 is normally sealed with a rubber disk (not shown) across the top surface of stopper 8, and this disk is held there by a tearable aluminum cap. The aluminum cap and rubber disk are removed to give access to stopper 8. Extending through an entrance port of the stopper 8 is an outlet spike 11 of drip housing 12. The lower end of drip housing 12 is connected to outlet tube 13 which leads to a needle, not shown, inserted in the vein of the patient. An air tube 6 extends part way through stopper 8 and is held in an upright position by this stopper, and in normal operation allows air to enter the primary bottle 1. However, in FIGURE 1, the inlet air tube 6 has been blocked off by means of plug 16 inserted in stopper 8.

A secondary bottle 2, shown containing blood, is supported from stand 3 by bail 5. The inverted secondary bottle 2 has its mouth closed by stopper 21 held in place by metal band 10. Air tube 7 allows air to be drawn into the secondary bottle to replace the blood that has been administered. Under normal administration of blood, only air at atmospheric pressure is drawn in through air tube 7. However, in extreme emergency, it may be necessary to very quickly administer the blood. This can be done easily with our apparatus by attaching a handoperated air pump (not shown) to the air inlet passage of the secondary bottle, and pressurizing the air above the blood. Suitable steps must of course be taken to assure that the pressure is released when the secondary bottle is empty.

Connecting the primary bottle and secondary bottle 2 is a connecting tube 19, one end of whichis connected to drip housing 18 having an outlet spike 17 inserted through stopper 21 of the secondary bottle 2. Drip housing 18 may include a blood filter (not shown) if desired. Attached to the opposite end of connecting tube 19 is an inlet spike hub 15 with its inlet spike 14 inserted through stopper 8 of the primary bottle 1. A clamp 2tlis positioned on connecting tube 19 to start or stop fluid flow through this connecting tube.

FIGURE 3 shows the top surface of stopper 8 as it would be seen when inserted in an upright bottle. However, when the bottle is inverted as in FIGURE 1, the surface of stopper 8 would actually be facing downward. The stopper 8 has an open outlet passage 22 with a tapered approach 23 for insertion of outlet spike 11. Air passage 42 extends through stopper 8 and allows air tube 6 to draw air into the primary bottle when not closed 011? by plug 16. A third or series-connecting passage 24, having a tapered approach 26, is closed by a puncturable, resealable diaphragm 25. This diaphragm 25 can be punctured by either an inlet spike 14, the spike of a vial containing additive medicaments for the fluid container, or the needle of a syringe containing additive medicaments for the fluid container. Because the opening of the third passage 24 is relatively small, alignment marks 27 are provided about the opening to make it easier to align the puncturing needle or spike with the passage.

Referring now to FIGURE 4, stopper 8 is shown crosssectioned through the outlet and air passages. Air passage 42 has a large-diameter, cylindrical, lower bore section 35 of appropriate size so that the walls grip and support air tube 6, which may be made of either glass or plastic. Air passage 42 also has a small-diameter, cylindrical, upper bore section 33 which is adapted to seal around a projecting shaft 31 of plug 16. A shoulder between bore sections 33 and 35 serves as a stop against which the top of air tube 6 rests. When the plug 16 is in position in air passage 42, the plug shaft 31 fits tightly within plug-sealing bore section 33 to form an airtight seal. This seal must hold even when air pressure is applied to the air inlet of the secondary container to expedite administration of blood as in a severe emergency. T provide stability and also to serve as a guide when plug 16 is inserted into stopper 8, a plug guide 30 extends axially from the end of plug shaft 31. This plug guide fits inside air tube 6. Plug 16 is provided with a large, flat plug handle 32 which extends to one side of plug shaft 31 to give ample grasping surface at a location spaced from the openings of both the outlet and air passages.

Outlet passage 22 is defined by a lower cylindrical wall section 29 extending part way through stopper 8, an inwardly tapering wall section extending upwardly from cylindrical section 29, a narrow sealing wall section 28 and a tapered approach 23. Tapered approach 23 bevels inwardly from the top of stopper 8 and connects with sealing wall section 28 to guide a spike into said section.

In FIGURE 5, the series-connecting passage 24 is shown in cross-section. This passage 24 is closed near the top stopper surface by a puncturable, resealable diaphragm 25, the top side of which defines a circular recess 36 and the bottom side of which defines a concavely curved end 39 of the lower portion 38 of passage 24. The diaphragm 25, which has a thin center, progressively thickens radially toward its periphery. A diaphragm of this configuration is more easily punctured and seals better than one of constant thickness. The thin center section causes little resistance to penetration by the point of a spike, and the thicker portion of the diaphragm firmly grips the body of a spike once it is'inserted. Alignment marks 27 about series-connecting passage 24 are shown in raised detail but indentations or other aligning marks may be used in their place about the opening of passage 24. At the upper edge of stopper 8 is a flange 40 extending en.-

tirely around the stopper and adapted to fit on the lip of the mouth of the primary bottle 1. If desired, a similar stopper may also be used to close the mouth of the secondary bottle 2.

FIGURE 2 shows in more detail the configuration of airway plug 16 and its plug handle 32, plug shaft 31, and plug guide 30 with its tapered tip 41. The material from which plug 16 is made can be very important, particularly when air tube 6 is made of breakable material such as glass. If the plug is molded from a flexible material such as low density polyethylene, the tapered tip 41, the plug guide 30 and plug shaft 31 will bend easily and will be diflicult to insert into stopper 8. On the other hand, if plug 16 were molded from a very rigid material, such as rigid polyvinyl chloride, the plug if cocked sideways would be very likely to break off a portion of glass air tube 6. We have found that an airway plug molded of medium density polyethylene is particularly suitable.

The procedure for connecting primary and secondary bottles in series is quite simple. First, a primary bottle, containing for example a parenteral solution of 5% dextrose in water, is connected to the patient in the usual manner and administration is started through outlet tube 13. At any time before the primary bottle is empty, the secondary bottle, which may for example contain blood, can be connected in series. To accomplish this, outlet spike 17 attached to drip housing 18 is inserted into the stopper 21 of secondary bottle and the secondary bottle inverted and hung on stand 3. During the connection of the two bottles, clamp 20 remains closed. Next, spike 14 is inserted into stopper 8 and plug 16 is inserted into stopper passage 42 to close olf the opening into air tube 6. Upon opening clamp 20 the blood begins to run through connecting tube 19 and up through spike 14 into primary bottle 1. Since the blood has a higher specific gravity than the parenteral solution, it tends to remain as a bottom layer with a minimum of mixing. This layer of blood will then drain out through outlet spike 11 and through outlet tube 13 into the patient. It is preferable to employ a spike 14 which has radial side ports so the blood can flow horizontally into the primary bottle rather than vertically through an end port of the spike 14. Side ports cause less mixing of the blood and parenteral solution, and the blood can be administered with very little dilution.

If the primary and secondary bottles remain connected as shown in FIGURE 1, the secondary bottle of blood will be administered to the patient before the parenteral solution in primary bottle 1 will begin flowing again. When secondary bottle 2 empties, air will be drawn through outlet spike 17 through connecting tube 19 and bubble out of spike 14, thereby allowing the parenteral solution in the primary bottle to drainthrough outlet spike 11. This can be avoided with our apparatus by merely detaching the secondary bottle 2 and removing the plug 16. p

In certain situations, particularly with infants, it may} not be feasible to administer the Whole pint of blood before the parenteral solution administration is resumed. A switch back to the parenteral solution before the secondary bottle 2 completely drains canbe accomplished with our device merely by closing clamp 20 and removing plug 16. Clamp 20. prevents any further blood from entering primarybottle .1 and removal of plug 16 allows air to again be drawn into the space above the parenteral solution. Now, if blood is again desired to be administered, the administration can be switched back to blood merely by inserting plug 16 and opening clamp 20. A great deal of flexibility is thus provided with the present series hook-up. because the system can be switched back and forth between parenteral solution administration and blood administration.

While parenteral solution has been shown in the primary bottle and blood shown in, the secondary bottle as an example, the series hook-up will work just as well for connecting 1) two bottles of blood, (2) two bottles of the same parenteral solution, or (3) primary and secondary bottles of different but compatible parenteral solutions.

While we have shown and described an embodiment of our invention, those skilled in the art will understand that certain modifications can be made without departing from the spirit and scope of our invention.

We claim:

1. An apparatus for administering parenteral fluids comprising:

(a) a primary bottle with a mouth opening;

(b) a secondary bottle with a mouth opening sealed by a closure;

(0) a stopper closing the mouth of said primary bottle, said stopper having an air inlet passage, a fluid outlet passage, and a series-connecting passage closed off by a puncturable resealable diaphragm;

(d) an air tube having one end permanently connected to the stopper air inlet passage and having an opposite end adjacent the bottom of the primary bottle so that this opposite end is above the fluid level when the primary bottle is in a mouth-downward position;

(e) a removable plug fitting in the stopper air inlet passageway to selectively open said air inlet passage when only fluid from the primary bottle is to be infused, said removable plug including (1) a plug shaft adapted to form an air-tight seal in the air inlet passage,

(2) a handle afiixed to one end of said plug shaft and extending way from said inlet passage, said handle allowing aseptic insertion and removal of said plug without touching said shaft, and

(3) a plug guide extending axially from an opposite end of said plug shaft and adapted to telescope into a portion of the air tube;

(f) conduit means connected at one end of the closure of said secondary bottle to drain the fluid from said secondary bottle; and

(g) a hollow spike for piercing said resealable diaphragm connected at an opposite end of said conduit means, said spike fitting in said series connecting passage of the primary bottle stopper and discharging fluid into the primary bottle at an end adjacent the stopper, said spike forming an air-tight seal at the puncturable resealable diaphragm.

2. A method of administering two different parenteral liquids from two stoppered parenteral liquid containers, the stoppers of each container having a liquid outlet passage, a diaphragm-closed passage, an open air inlet passage and an air tube extending from said air inlet pass-age into the container, said method comprising the steps of:

(a) commencing the infusion of liquid from the first contain-er into a vein of a patient by (1) connecting one end of an administration set to the outlet passage of the first of said containers,

(2) connecting the opposite end of this administr-ation set to a patient, and

(3) filling the administration set with liquid from the first of said containers;

(b) connecting one end of a conduit means to the liquid outlet of the second of said containers;

(c) connecting the opposite end of said conduit means to the diaphragm-closed passage of the first of said containers and simultaneously piercing the diaphragm of this passage, thereby infusing liquid from said second container into said first container at an end adjacent the first container stopper, the liquid from the second container having a higher specific gravity than liquid from the first container;

(d) inserting a removable plug into the air inlet passage of said first container, thereby sealing off air flow through this passage and said air tube to cause liquid from said second container to flow directly into the first container adjacent its stoppered end and directly therefrom into the administration set;

(e) withdrawing at least a portion of the liquid of said second container into said first container; and

(f) changing to administration solely from the first container by (1) shutting off the liquid flow through the conduit means and (2) removing the plug from the air inlet passage of said first container.

References Cited by the Examiner UNITED STATES PATENTS 2,190,054 2/1940 Cuttes et al. 128-214 X 2,202,163 5/1940 Mulford et al. 128-214 2,210,098 8/1940 Ravenscroft 128-214 2,603,218 7/1952 Rane 215-47 X 2,644,453 7/1953 Beacham 128-272 2,923,293 2/1960 Nawoj et al. 128-272 3,064,653 11/1962) Coanda 128-348 FOREIGN PATENTS 966,701 9/1957 Germany.

RICHARD A. GAUDET, Primary Examiner. 

1. AN APPARATUS FOR ADMINISTERING PARENTERAL FLUIDS COMPRISING: (A) A PRIMARY BOTTLE WITH A MOUTH OPENING; (B) A SECONDARY BOTTLE WITH A MOUTH OPENING SEALED BY A CLOSURE; (C) A STOPPER CLOSING THE MOUTH OF SAID PRIMARY BOTTLE, SAID STOPPER HAVING AN AIR INLET PASSAGE, A FLUID OUTLET PASSAGE, AND A SERIES-CONNECTING PASSAGE CLOSED OFF BY A PUNCTURABLE RESEALABLE DIAPHRAGM; (D) AN AIR TUBE HAVING ONE END PERMANENTLY CONNECTED TO THE STOPPER AIR INLET PASSAGE AND HAVING AN OPPOSITE END ADJACENT THE BOTTOM OF THE PRIMARY BOTTLE SO THAT THIS OPPOSITE END IS ABOVE THE FLUID LEVEL WHEN THE PRIMARY BOTTLE IS IN A MOUTH-DOWNWARD POSITION; (E) A REMOVABLE PLUG FITTING IN THE STOPPER AIR INLET PASSAGEWAY TO SELECTIVELY OPEN SAID AIR INLET PASSAGE WHEN ONLY FLUID FROM THE PRIMARY BOTTLE IS TO BE INFUSED, SAID REMOVABLE PLUG INCLUDING (1) A PLUG SHAFT ADAPTED TO FORM AN AIR-TIGHT SEAL IN THE AIR INLET PASSAGE, (2) A HANDLE AFFIXED TO ONE END OF SAID PLUG SHAFT AND EXTENDING WAY FROM SAID INLET PASSAGE, SAID HANDLE ALLOWING ASEPTIC INSERTION AND REMOVAL OF SAID PLUG WITHOUT TOUCHING SAID SHAFT, AND (3) A PLUG GUIDE EXTENDING AXIALLY FROM AN OPPOSITE END OF SAID PLUG SHAFT AND ADAPTED TO TELESCOPE INTO A PORTION OF THE AIR TUBE; (F) CONDUIT MEANS CONNECTED AT ONE END OF THE CLOSURE OF SAID SECONDARY BOTTLE TO DRAIN THE FLUID FROM SAID SECONDARY BOTTLE; AND (G) A HOLLOW SPIKE FOR PIERCING SAID RESEALABLE DIAPHRAGM CONNECTED AT AN OPPOSITE END OF SAID CONDUIT MEANS, SAID SPIKE FITTING IN SAID SERIES CONNECTING PASSAGE OF THE PRIMARY BOTTLE STOPPER AND DISCHARGING FLUID INTO THE PRIMARY BOTTLE AT AN END ADJACENT THE STOPPER, SAID SPIKE FORMING AN AIR-TIGHT SEAL OF THE PUNCTURABLE RESEALABLE DIAPHARAM. 